10:48 AM EDT, 05/27/2025 (MT Newswires) -- Ocugen ( OCGN ) said Tuesday it has received rare pediatric disease designation from the US Food and Drug Administration for its gene therapy candidate, OCU410ST, to treat ABCA4-associated retinopathies such as Stargardt disease.

Ocugen ( OCGN ) said it may be awarded a Priority Review Voucher, if the program is reauthorized by the US Congress. A PRV can be redeemed to receive priority review for another product or sold to another sponsor and typically sells for about $100 million.

Ocugen ( OCGN ) said it plans to begin a phase 2/3 trial in the coming weeks, with a target Biologics License Application filing in 2027.

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